Karen Zaderej
Analyst · Leerink Partners. Please state your question
Thanks, Kaila, and good afternoon, everyone. Second quarter revenue grew 30% to $26.7 million. We're pleased with our continued growth and the progress we've made in strengthening our commercial execution. Sales in the quarter came in at the low end of our annual guidance range due primarily to delayed productivity growth. As a result, we're updating our guidance for the year to reflect this current run rate. We now expect revenues will be in the range of $106 million to $110 million, representing growth of 26% to 31% for the full year. We now have 100 direct sales representatives and expect to continue to grow to at least 115 by the end of this year. The new reps allows to split larger territory, add clinical sales specialists and convert independent agency territories to direct. We've increased the number of direct reps by 40% and our direct business now represents 87% of our revenue versus approximately 80% one year ago. Our direct coverage is much improved over the prior year, with smaller, more dense territories, which we believe will drive productivity improvement as the structure matures. These are important and strategic initiatives that will allow us to continue to drive long-term sustainable growth in the developing market. We're the leading company solely dedicated to restoring quality of life for patients suffering from peripheral nerve damage. Our purpose-driven team of professionals works with skilled clinicians to further our mission to deliver life-changing evidence-based solutions to better serve its patient population. We're advancing this mission through the pursuit of our strategic initiatives, which we refer to as our five pillars of growth, building market awareness, educating surgeons and developing advocates, growing the body of clinical evidence, executing on our sales plan and introducing new products and expanded applications in nerve repair. I'll now comment on our progress in each of these areas. First, we continue to build market awareness of AxoGen in our products by engaging with patients and surgeons. We are growing clinical awareness of our products and nerve repair algorithm within the surgeon community. In the quarter, we've participated in the 2019 meeting of the International Federation of societies for surgery of the hand a clinical conference to hand surgeons from around the world. There were 10 scientific presentations related to AxoGen's products. In addition to these presentations we hosted two educational symposiums focused on optimizing outcomes by utilizing AxoGen's peripheral nerve repair algorithm. These symposiums were highly attended and provided increased awareness of clinical evidence supporting the use of our portfolio of nerve repair products. Our second pillar of growth is focused on surgeon education and the development of surgeon advocates. We conducted seven national education programs in the second quarter, including one Fellows program. We're also growing the number of educational programs specific to our specialty applications including OMF and breast reconstruction. The surgeon led events focus on advances and best practices in nerve repair with participating surgeons gaining confidence in nerve repair techniques. On average, we see Axogen product utilization from surgeon attendees more than double in the six months after they attend the program. In 2019, we plan to conduct a total of 25 national education programs, including six Fellows programs. We remain committed to training the next generation of neurosurgeons and expect to train three quarters of all hand and microsurgery fellows this year Our third pillar is to grow the body of clinical evidence. Recently, we announced the publication of the 100th peer-reviewed paper featuring results from clinical studies involving our product portfolio, an important milestone for Axogen that reinforces our ongoing commitment to advancing clinical evidence and peripheral nerve repair. Favorable results have been replicated across both sponsored and independent investigator initiated studies evaluating our technology. With more than 10 years of comprehensive clinical evidence demonstrating positive outcome, we are seeing growing surgeon interest and acceptance of the Axogen portfolio of products. We will continue to sponsor clinical research where we believe we can make a meaningful difference. In late April, we provided an update on RECON, our Phase III pivotal study to support our BLA for Avance nerve graft. This prospective randomized controlled double-blinded study compares Avance Nerve Graft to synthetic conduits. Specifically, we announced the completion of the blinded interim analysis and our plan to expand enrollment by 50 subjects to support the original power of the study. Over half of our study sites have now been reinitiated and are actively recruiting study subjects and we're in the process of selecting and onboarding up to five new centers. We started the enrollment of additional subjects and continue to anticipate we will reach our goal of 220 subjects by the end of summer 2020. Our RANGER registry has now enrolled more than 1,800 Avance Nerve Graft repairs and continues to provide significant new evidence in the management of nerve injuries. Data from the registry continues to demonstrate meaningful recovery treating a variety of nerve injuries and gap lengths. The data demonstrates the ability to restore sensory and motor function and shows positive outcomes while eliminating the donor-site comorbidities associated with autograft. Surgeons are using this clinical data to better understand nerve repair outcomes and to expand their treatment algorithms. We also continue to enroll the MATCH study, which is a contemporary cohort control within the RANGER study that provides reference controls for nerve autograft and synthetic conduits from participating registry centers. We expect data from this study will be presented later this year. Additionally, we continue to enroll subjects and build clinical evidence in the Sensation Neurotization Outcomes for Women, or Sensation-NOW, clinical registry. We believe the data from this registry will demonstrate that the Resensation technique provides meaningful recovery of sensation and improved quality of life for women who choose neurotization along with their flat reconstruction following vasectomy. In 2018, we initiated our REPOSE clinical study. REPOSE is a prospective, randomized-controlled study evaluating the use of AxoGuard Nerve Cap in the management of painful neuroma as compared to a standard neurectomy procedure. REPOSE is a two-phased study, consisting of 15 subject pilot and an 86 subject pivotal phase. We have completed enrollment of the pilot, and we've initiated enrollment of the pivotal phase of the study. Recently, we have also begun enrollment in our ASSIST clinical study. ASSIST is a cohort study that evaluates the use of Avive Soft Tissue Membrane as compared to a non-treatment control in non-transacted acute traumatic nerve injuries. This study will enroll over the next several years and includes a one-year follow up. Our fourth pillar is sales execution. We continue to grow and refine our commercial capabilities across our three core nerve repair applications. We ended the quarter with a total of 100 direct sales representatives, an increase of seven in the quarter and 28 over the last 12 months. We ended the quarter with 19 independent agencies. We have converted certain independent territories to direct territories, as well as adding new agencies. We expect to continue to add agencies in select geographies. With an expanded sales footprint, we've been able to reduce territory size and we believe this will create efficiencies for our direct sales team, allowing them to drive deeper penetration in our current active accounts while also adding new active accounts. In the second quarter, our number of active accounts increased 20% to 762, up from 634 in the second quarter of 2018. We define an active account as an account that has typically gone through the committee approval process as at least one surgeon who has converted a portion of his or her nerve repair algorithm to the AxoGen portfolio and has ordered the AxoGen products at least 6 times in the last 12 months. Our objective is to continue expanding the treatment algorithms of surgeons to include all surgical implant products across our full continuum of nerve repair. This is important because accounts ordering at least three of our four nerve repair products generate more than six times the revenue of an account ordering just one of these products. Our fifth pillar of growth is the introduction of new products and expanded applications in nerve repair. We are making investments in opportunities to innovate our product portfolio and to expand the application of our nerve repair products to address the many unmet needs in the surgical repair of peripheral nerves. In November of last year, we announced several foundational initiatives planned for 2019 to help support a broader introduction into the surgical treatment of pain. A nerve repair application, we believe, could expand our total addressable market. As we've discussed, one of the sources of chronic pain following traumatic injuries or orthopedic procedures is a symptomatic neuroma. Surgeons can surgically remove the neuroma and repair the resulting nerve injury using our products. As we explore this market opportunity, we see significant surgeon interest in treating this under-served patient population. Before I turn the call over to Pete, I want to reiterate that I'm pleased with our progress as we continue to execute against our strategic initiatives in a large and developing market. I'm confident we're building strong capabilities to drive long-term sustainable growth across an expanding set of nerve repair applications. Now, I'll turn the call over to Pete for a review of our financial highlights. Pete?